Bortezomib and Lenalidomide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00553644
First received: November 2, 2007
Last updated: May 7, 2014
Last verified: March 2014
Results First Received: January 6, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Recurrent Mantle Cell Lymphoma
Interventions: Drug: bortezomib
Drug: lenalidomide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between November 2007 and July 2011, 54 participants were recruited to this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One participant was deemed ineligible and removed for all analyses; therefore, 53 participants were analyzed.

Reporting Groups
  Description
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)

Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.

bortezomib: Given IV

lenalidomide: Given PO


Participant Flow:   Overall Study
    Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)  
STARTED     53  
COMPLETED     25  
NOT COMPLETED     28  
Adverse Event                 17  
Withdrawal by Subject                 4  
Physician Decision                 1  
Alternative therapy                 6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)

Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.

bortezomib: Given IV

lenalidomide: Given PO


Baseline Measures
    Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)  
Number of Participants  
[units: participants]
  53  
Age  
[units: years]
Median ( Full Range )
  67  
  ( 39 to 83 )  
Gender  
[units: participants]
 
Female     9  
Male     44  
Region of Enrollment  
[units: participants]
 
United States     53  



  Outcome Measures

1.  Primary:   Number of Participants With an Overall Response Defined as Complete Response and Partial Response   [ Time Frame: Duration of treatment (assessed up to 6 years) ]

2.  Secondary:   Incidence of Adverse Events   [ Time Frame: Assessed up to 6 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Time to Progression   [ Time Frame: Assessed up to 6 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Overall Survival   [ Time Frame: Assessed up to 6 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Vicki Morrison, M.D.
Organization: Veterans Affairs Medical Center/University of Minnesota
e-mail: morri002@umn.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00553644     History of Changes
Other Study ID Numbers: NCI-2009-00483, NCI-2009-00483, CDR0000573827, CALGB-50501, CALGB 50501, CALGB-50501, P30CA014236, U10CA031946
Study First Received: November 2, 2007
Results First Received: January 6, 2014
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration